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K Number
K070611
Device Name
BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6
Manufacturer
NOMOS CORP.
Date Cleared
2007-07-11

(128 days)

Product Code
IYE
Regulation Number
892.5050
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

BAT can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images. BAT can be used for general imaging for small organs (breast, thyroid, testes), abdominal, trans-esophageal (noncardiac), trans-rectal, trans-vaginal, and musculo-skeletal (superficial and conventional) applications.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the BAT device, indicating that the device has been found substantially equivalent to a legally marketed predicate device for its indicated uses.

The letter lists the device name, regulation numbers, regulatory class, product codes, and the indications for use, but it does not detail:

  • Specific acceptance criteria.
  • Results of a performance study that quantitatively demonstrates the device meets certain metrics.
  • Information about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide the requested table and information based on the text provided.

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.